New hope for ITP patients: drug combo aims to boost platelets
NCT ID NCT07234019
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding an anti-CD38 antibody to the standard drug rituximab works better than rituximab alone for adults with immune thrombocytopenia (ITP) whose platelet counts stayed low or came back after steroid treatment. About 160 participants will receive either the combination or rituximab alone. The main goal is to see if more people reach a safe platelet level by week 12 without needing extra rescue therapy.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 160 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Nov 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥18 years, male or female. * Before enrollment, the subjects have been clinically diagnosed with primary immune thrombocytopenia for no less than three months according to the American Society of Hematology guidelines 2011 Evidence-Based Practice Guideline (Neunert et al. 2011) or the International Consensus Report for the Investigation and Management of Primary Immune Thrombocytopenia (Provan et al. 2010), as applicable locally. * Subjects with a platelet count of \<30×10\^9/L within the 48 hours prior to the first dose of the study drug;The platelet count of at least two separate assessments (at least 1 week apart) \<30×10\^9/L during the screening visit. * Patients have failed glucocorticoid therapy (either due to inefficacy, efficacy could not be maintained, or relapse). * Previous emergency treatment for ITP (e.g., methylprednisolone, platelet, gamma globulin infusion) must have been completed at least 2 weeks before the first dose. * Hepatic and renal function (e.g., alanine aminotransferase, aspartate aminotransferase, total bilirubin, serum creatinine) \<1.5 times the upper limit of normal (ULN). * ECOG performance status score of ≤2. * Cardiac function: New York Heart Association (NYHA) class ≤2. * Enrollment of subjects receiving maintenance therapy is permitted, including glucocorticoids (≤0.5 mg/kg of prednisone or equivalent) or TPO receptor agonists, but the concomitant medication must have been stable for a minimum of 4 weeks prior to the initial infusion of the study drug; Azathioprine, danazol, cyclosporine A, tacrolimus, sirolimus, etc. must be stopped at least 4 weeks before the first dose; CD20 monoclonal antibody such as rituximab must have been stopped for more than 6 months; the interval between splenectomy and first administration need to be more than 6 months. * For fertile female patients, a negative pregnancy test result is required. Fertile female and male patients must use effective contraception separately during the study and for 90 days after the cessation of study drug treatment. * Subjects comprehensively understand and can adhere to the study protocol requirements and willingly signed the informed consent form. Exclusion Criteria: * Uncontrollable primary diseases of important organs, such as malignant tumors, liver failure, heart failure, renal failure and other diseases. * HIV positive. * Accompanied by uncontrollable active infection, including hepatitis B, hepatitis C, cytomegalovirus, EB virus and syphilis positive. * Accompanied by extensive and severe bleeding, such as hemoptysis, upper gastrointestinal hemorrhage, intracranial hemorrhage, etc.. * At present, there are heart diseases, arrhythmias that need treatment or hypertension that researchers judge is poorly controlled. * Patients with thrombotic diseases such as pulmonary embolism, thrombosis and atherosclerosis. * Those who have received allogeneic stem cell transplantation or organ transplantation in the past. * atients with mental disorders who cannot normally obtain informed consent and conduct trials and follow-up. * Patients whose toxic symptoms caused by pre-trial treatment have not disappeared. * Other serious diseases that may limit the subject's participation in this test (such as diabetes; Severe cardiac insufficiency; Myocardial obstruction or unstable arrhythmia or unstable angina pectoris in recent 6 months; Gastric ulcer, etc.). * Patients with septicemia or other irregular severe bleeding. * Patients taking antiplatelet drugs at the same time. * Pregnant women, suspected pregnancies (positive pregnancy test for human chorionic gonadotropin in urine at screening) and lactating patients. * Subjects with a known allergy to medications were used in the trial or excipients. * Any other conditions unsuitable for participation in this study, as assessed by the investigator.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Chinese Academy of Medical Science and Blood Disease Hospital
RECRUITINGTianjin, Tianjin Municipality, 300020, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- What Trade-Offs are ITP patients willing to make for better treatment?
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- Can a new drug calm the immune System's attack on blood cells?